Intramedullary pin for insertion into the medullary space of a femur

ABSTRACT

An intramedullary pin for insertion into the medullary space of the femur through the lateral compacta of the trochanter major. The pin has a proximal pin section and an adjoining distal pin section. Each pin section includes one or more bores for one or more bone screws. The proximal pin section has at least one bore running obliquely to the longitudinal axis, so that bone screws can be inserted through the bore into the head of the femur, or a screw can be inserted in the antegrade direction through the bore. The distal pin section is at least partly straight and the proximal pin section has a curvature in the lateral-posterior direction.

CROSS REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.11/787,261 filed on Apr. 13, 2007, now U.S. Pat. No. 8,317,788, which isa continuation of International Patent Application No.PCT/IB2004/003425, filed Oct. 20, 2004, which claims benefit of U.S.Prov. Patent Appln. Ser. No. 60/522,568 filed on Oct. 14, 2004, theentire contents of which is expressly incorporated herein by reference.

TECHNICAL FIELD

The present invention relates an intramedullary pin for insertion intothe medullary space of a femur.

BACKGROUND OF THE INVENTION

It is known in the art to use intramedullary pins. U.S. Pat. No.6,461,360B1 describes an intramedullary pin for osteosynthesis. Beforeinsertion into a femur, the intramedullary pin has, at its distal end,in the sagittal plane, a curvature which corresponds to thecounter-curvature of the femur. The proximal end substantially has acontinuous curve with constant radius of curvature in the frontal plane.

U.S. Pat. No. 6,010,506 discloses a hybrid pin having different radii,all of which extend in a plane.

International publication WO 02089683 discloses an intramedullary pinusing helix geometry. This structure ensures that the entry point for apin inserted in an antegrade direction can be displaced laterally fromthe trochanter tip. On insertion of the pin, the pin rotates throughabout 90°. The rotation of the pin is influenced substantially by itshelix geometry. The inner wall of the medullary space and spongiosaserve here as a guide structure.

There are disadvantages to using a pure helical geometry in varyinganatomy of bones. In one instance, on reaching the end position, thedistal locking holes may not be in lateral medial alignment. To correctthis, the pin must be either inserted further or drawn back. The pinwould rotate about its longitudinal axis as a result of either beinginserted further or being drawn back. This consequently results in anundesired change of height of the locking position. On reaching the endposition, the screws thus cannot be introduced centrally through theneck of the femur for locking in the head of the femur. In anotherinstance, if only rotation is to be corrected, this can lead to adisplacement of the implant depth of the pin and hence to an undesiredchange in the height of the locking position. If the proximal pin end isnot yet completely in the bone, the pin must be inserted more deeply.This, however, results in an undesired continuation of the rotationalmovement. As a result of this, the optimum positions of the lockingoptions are once again changed.

SUMMARY OF THE INVENTION

The present invention is to provide a remedy for the above-discusseddisadvantages. It is an object of the invention to create anintramedullary pin where the distal locking holes are preferablyparallel to the frontal plane or in lateral/medial alignment when thepin comes to rest in its final implantation depth range. Theintramedullary pin may then be fixed in the proximal region by means ofscrews which are inserted through the neck of the femur into the head ofthe femur. To accomplish this, the implantation depth of the pin must besuch that the screws may be passed centrally through the neck of thefemur. The neck of the femur and head are, however, rotated relative tothe frontal plane about the longitudinal axis of the femur. Thisrotation is described as the anteversion angle, meaning that the pinmust be adapted to the anatomically changing anteversion angles byrotation of the pin about its longitudinal axis. This is intended toensure that the screws may be placed centrally through the neck of thefemur and centrally in the head. Furthermore, the proximal pin endshould be flush with the surrounding cortex or deeper. This is intendedto prevent the surrounding tissue from being irritated by the proximalpin end.

It is therefore an object to provide an intramedullary pin that need nothave an adapted geometry for every femur bone exhibiting differentgrowth, in order to fulfill the abovementioned conditions. The presentinvention accomplishes the objective set out above with anintramedullary pin where the end of the helical shape are modified.Specifically, the proximal end of the pin is curved in a plane, whilethe distal end remains straight. This ensures that, on reaching thefinal implantation depth range, the intramedullary pin ceases to rotateby itself. In the final implantation depth range, the pin may bedisplaced along its longitudinal axis without change of rotation. Thepin may nevertheless be arbitrarily rotated about its longitudinal axiswithout changing its implantation depth.

While the distal pin section therefore has, at least partly, nocurvature at all, the proximal pin section run traverses the lateralposterior direction when it is inserted into the medullary space throughthe lateral compacta of a trochanter major.

By changing the ends of the helical shape, it is possible to produce anintramedullary pin which functions optimally for a certain group ofbones. Variation in anatomy no longer has an effect on the functionalityof the pin. The intramedullary pin may be optimally oriented for lockingin the bone.

The intramedullary pin according to the invention preferably has, in theproximal region, at least has two bores running obliquely to thelongitudinal axis and parallel to one another and a third boreintersecting the first two bores. The orientation of the three boresallows for a combination of possibilities for locking the intramedullarypin, where antegrade locking has particular importance. A new lateralopening for the intramedullary pin approximately coincides with theinsertion direction of the antegrade screw. If only one screw is setproximally, no further skin incision is therefore necessary.

In another embodiment, the pin preferably has two bores runningtransverse to the pin's longitudinal axis and parallel to one anotherand, at the distal end, a bore which is arranged in between the twobores, is rotated about the longitudinal axis relative to the planedefined by the two bores and likewise runs transverse to the pin'slongitudinal axis. The middle locking bore is rotated through 25°relative to the left and right locking bores. A feature of the distalarrangement of the three bores lies in the combination of thepossibilities for locking. In addition to the generally known standardlocking, a third bore is present between the two standard bores. Bylocking the pin with three screws, axial stability is achieved. Thisensures that the position of the distal pin end is fixed and the pincannot be displaced on the screws. The 25° angle of the axial blockingscrew may prevent the screw from injuring important soft tissues duringinsertion. This can occur, for example, if the screw is inserted in thesagittal direction (90°). The locking screws may be present at adistance of about 30 mm away from one another.

In another embodiment, an intramedullary pin, having a longitudinal/pinaxis, for insertion into a medullary space of a femur through thelateral compacta of the trochanter major, comprises a proximal pinsection and an adjoining distal pin section, respectively having aproximal end plane and distal end plane. The proximal pin sectionincludes a proximal end, a 120° antegrade bore compatible with a lockingscrew having a thickness of about 5.0 mm thick, and a cranial 130° reconbore compatible with a headless screw of about 6.5 mm thick, where therecon bore coincides medially with the antegrade bore. The proximal pinsection also includes a caudal 130° recon bore compatible with aheadless screw having a thickness between about 3.9-6.0 mm, and an ovalbore for static and dynamic positioning of a locking screw having athickness of about 3.9-6.0 mm. The distal pin section includes a tip,two bores transverse to the longitudinal axis of the pin and parallel toone another; and an anterolateral bore rotated through 25° relative tothe two bores.

For proper implantation, it is very important to be able to recognizethe end of the pin clearly with the aid of an imaging method (X-rays).This is not possible or possible only to an insufficient extentaccording to the prior art to date. Incorrect insertion depth might havethe following consequences: if the pin does not come to restsufficiently deep in the bone, the projecting pin end may result incomplications such as pain, necrosis, etc. If the pin is implanted toodeep, the result may be offset of the proximal pin end. Furthermore,ingrowth of bone may occur so that the upper part of the originalinsertion channel is closed. These possibilities complicate thesubsequent explanation of the intramedullary pin (implant). Moreover,there is the danger that the tip of the pin will penetrate into theknee.

For introduction of the implant, the pin is connected to a target bow.This usually rests flat on the end of the pin. It results in acontinuous transition and contour matching between pin and target bow. Abevel which interrupts the transition and the contour matching betweenthe target bow and pin is preferably formed laterally at the proximalend of the pin according to the invention. In the case of ananterior-posterior X-ray photograph, the end of the pin is, as a result,easily and clearly detectable. This simplifies the surgery and leads tosafer use and a shorter operation time. The pin entry point is on thelateral surface of the trochanter major. This surface can be palpatedparticularly in slim patients. This means that the surface is coveredonly by a thin layer of skin. Through the lateral entry point of thepin, it is necessary to prevent the soft tissue from being irritated bythe proximal pin end. An advantage of the bevel is that the bevel alsoensures that the proximal pin end fits the lateral cortex wall with amatching contour. This prevents irritation of the soft tissue.

A groove by means of which the rotation of the pin on the target bow isfixed is preferably present on the medial side of the proximal end. Incomparison, the prior art comprises rotational fixing via two grooves,which, however, result in a higher manufacturing cost.

A cylindrical recess into which the diametrically opposite shaft of theconnecting screw can penetrate between the target bow and pin is presentat the proximal end. Consequently, the pin axis is aligned coaxiallywith the target bow, the thread exerting only the contact pressure. Incomparison, the prior art comprises the coaxial alignment directly andonly by the thread of the connecting screw.

A special formation of the tip allows the pin to be tapped withoutrotation into the spongiosa in the distal femur region. This preventsrotation of the pin even without the use of a locking screw. The tip ofthe pin has, in a radial section, differing from the circular shape,special tip surfaces, in particular concave notches or planar surfaces.Use of such tips prevent subsequent, arbitrary or involuntary rotationis not possible.

BRIEF DESCRIPTION OF THE DRAWINGS

The intramedullary pin is explained in even greater detail in thefollowing exemplary drawings. The intramedullary pin may be betterunderstood by reference to the following drawings, wherein likereferences numerals represent like elements. The drawings are merelyexemplary to illustrate the structure, operation and method of use ofthe intramedullary pin and certain features that may be used singularlyor in combination with other features and the invention should not belimited to the embodiments shown.

The invention is explained in more detail schematically and by way ofexample with reference to figures.

FIG. 1 shows an intramedullary pin according to one embodiment of theinvention viewed in the anterior to posterior direction, i.e. in thelateral-medial plane,

FIG. 2 shows the intramedullary pin viewed in the lateral to medialdirection, i.e., in the anterior-posterior plane,

FIG. 3 shows the intramedullary pin viewed in the proximal to distaldirection,

FIG. 4 a shows a particular embodiment of the tip of the pin viewed inthe lateral to medial direction,

FIG. 4 b shows a particular embodiment of the tip of the pin viewed inthe distal to proximal direction,

FIG. 5 a shows a particular embodiment of the tip of the pin viewed inthe lateral to medial direction,

FIG. 5 b shows a particular embodiment of the tip of the pin viewed inthe distal to proximal direction,

FIG. 6 a shows a particular embodiment of the tip of the pin viewed inthe lateral to medial direction,

FIG. 6 b shows a particular embodiment of the tip of the pin viewed inthe distal to proximal direction and

FIG. 7 shows the proximal end of the tip viewed in the proximal todistal direction.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIGS. 1-3 depict an intramedullary pin 1 in three views. Theintramedullary pin 1 has a proximal end 14 and a distal end 15. Theshaft of the pin 1 is generally cylindrical in shape. The proximal end14 may be curved in a lateral-posterior direction, while the distal end15 may be straight or at least partly straight. Proximal and distal endplanes of the pin may be rotated about 60°-110°, preferably 70°-90° andin particular 80° relative to one another. In one embodiment, the radiusis between about 300-1300 mm, preferably about 900-1200 mm and inparticular about 1100 mm. The length of the proximal radius correspondsto the lateral contact surface with the cortex which is about 300-1000mm, preferably about 600-800 mm, and in particular 700 mm.

The length of the distal straight section may correspond to the depth towhich the distal pin end penetrates into the distal spongiosa structure.The length may be about 35-70 mm, preferably about 40-60 mm, and inparticular about 52 mm.

The pin 1, at the proximal end 14, may be designed with a 120° antegradebore 2 compatible with a locking screw having a thickness between about3.9-6.0 mm, a cranial 130° recon bore 3 compatible with a headless screwthat is about 6.5 mm thick. The 130° recon bore 3 may coincide mediallywith the 120° antegrade bore 2. The pin 1 may further be designed with acaudal recon bore 4 which is approximately 130° and compatible with aheadless screw that is about 6.5 mm thick, and an oval bore 5 for staticand dynamic positioning of a locking screw that is about 3.9-6.0 mmthick. Furthermore, a lateral bevel 9 is recognizable at the proximalend 14. The orientation of the three bores 3, 4, 5 allows for acombination of possibilities for locking the intramedullary pin, whereantegrade locking has particular importance. A lateral opening 2 for theintramedullary pin approximately coincides with the insertion directionof the antegrade screw. If only one screw is set proximally, no furtherskin incision is therefore necessary.

At the distal end 15, two bores 6 and 7 extend transverse to the pin'saxis 18 and parallel to one another. An anterolateral bore 8 which isrotated through about 25° relative to the parallel bores 6 and 7 isshown at the distal end 15. The angle formed between the anterolateralbore 8 and the parallel bores is preferably between about 45° and 10°,where 0° corresponds to the frontal plane or the plane of two standardlocking screws. A feature of the configuration of the three bores liesin the combination of the possibilities for locking. In addition to thegenerally known standard locking, the third bore 8 is present betweenthe two standard bores. By locking the pin with three screws, axialstability is achieved. This ensures that the position of the distal pinend is fixed and the pin cannot be displaced on the screws. The 25°angle of the axial blocking screw may prevent the screw from injuringimportant soft tissues during insertion. This can occur, for example, ifthe screw is inserted in the sagittal direction (90°). The lockingscrews may be present at a distance of about 30 mm away from oneanother.

Special formations at the tip 16 of the pin 1 allows the pin 1 to betapped without rotation into the spongiosa in the distal femur region soas to be secured, preventing rotation even without locking by means of ascrew. The tip 16 of the pin 1 may have, in a radial section, differingfrom the circular shape (cylindrical) of the body of the pin 1, specialtip surfaces, in particular concave notches or planar surfaces. In theseembodiments, subsequent, arbitrary or involuntary rotation is notpossible.

FIGS. 4 a and 4 b depict an embodiment of the tip 16 at the distal end15 of the pin 1 in two views. The tip 16 may have, in a radial section,differing from the circular shape, special tip surfaces 13, inparticular three planar surfaces, having a length of about 10-40 mm,preferably about 15-25 mm and in particular about 20 mm. The totallength of the tip 16 may be about 20-50 mm, preferably about 25-35 mmand in particular 30 mm. Bore 7 is shown near the tip 16 of the distalend 15.

FIGS. 5 a and 5 b depict another embodiment of the tip 16 at the distalend 15 of the pin 1 in two views. The tip 16 may have, in a radialsection, differing from the circular shape, special tip surfaces 13, inparticular three concave notches, having a length of about 10-40 mm,preferably about 15-25 mm and in particular about 20 mm, and a radius 17of about 4-10 mm, preferably about 5-8 mm and in particular about 6 mm.The total length of the tip 16 is about 20-50 mm, preferably about 25-35mm and in particular about 30 mm.

FIGS. 6 a and 6 b depict another embodiment of the tip 16 at the distalend 15 of the pin 1 in two views. The tip 16 may have, in a radialsection, differing from the circular shape, special tip surfaces 13, inparticular four concave notches, which have a length of about 10-40 mm,preferably about 15-25 mm and in particular about 20 mm, and a radius 17of about 4-10 mm, preferably about 5-8 mm and in particular about 6 mm.The total length of the tip 16 is about 20-50 mm, preferably about 25-35mm and in particular about 30 mm.

FIG. 7 shows the proximal end 14 of the pin 1 viewed in a proximal todistal direction. A lateral bevel 9, discussed previously, may form anangle at the lateral-proximal end relative to the axial pin axis 18 ofbetween about 10° to 60°, preferably about 40°. A cylindrical recess 12may have a thread 11, and a positioning groove 10 on the medial side ofthe proximal end 14, are shown.

The bevel 9 which interrupts the transition and the contour matchingbetween the target bow and pin 1 is preferably formed laterally at theproximal end 14 of the pin 1. In the case of an anterior-posterior X-rayphotograph, the end of the pin 1 can be easily and clearly detectable.This simplifies the surgery and leads to safer use and a shorteroperation time. The pin's entry point is on the lateral surface of thetrochanter major. This lateral surface can be palpated particularly inslim patients. This means that the surface is covered only by a thinlayer of skin. Through the lateral entry point of the pin 1, it isnecessary to prevent the soft tissue from being irritated by theproximal end 14 of the pin 1. An advantage of the bevel 9 is that thebevel 9 may ensure that the proximal end 14 fits the lateral cortex wallwith a matching contour. This may prevent irritation of the soft tissue.

While the distal pin section has, at least partly, no curvature at all,the proximal pin section may run in the lateral posterior direction whenit is inserted into the medullary space through the lateral compacta ofa trochanter major. The groove 10 which fixes the rotation of the pin 1on the target bow is preferably present on the medial side of theproximal end 14. The cylindrical recess 12 into which the diametricallyopposite shaft of a connecting screw can penetrate between target bowand pin 1 is present at the proximal end 14. Consequently, the pin axis18 is aligned coaxially with the target bow, and the thread 11 exertsonly contact pressure.

Although the present invention and its advantages have been described indetail, it should be understood that various changes, substitutions andalterations can be made herein without departing from the spirit andscope of the invention as defined by the appended claims. Moreover, thescope of the present application is not intended to be limited to theparticular embodiments of the process, machine, manufacture, compositionof matter, means, methods and steps described in the specification. Asone of ordinary skill in the art will readily appreciate from thedisclosure of the present invention, processes, machines, manufacture,compositions of matter, means, methods, or steps, presently existing orlater to be developed that perform substantially the same function orachieve substantially the same result as the corresponding embodimentsdescribed herein may be utilized according to the present invention.Accordingly, the appended claims are intended to include within theirscope such processes, machines, manufacture, compositions of matter,means, methods, or steps.

The invention claimed is:
 1. An intramedullary pin, comprising: an elongated shaft extending from a proximal end to a distal end along a central longitudinal axis, the shaft including a proximal section extending from the proximal end to a first end and a distal section extending from the first end to the distal end, wherein in the proximal section the longitudinal axis curves in a lateral-posterior direction from the proximal end to at least the first end; a first proximal bore extending through the proximal section along a first bore axis; and a second proximal bore extending through the proximal section along a second bore axis, wherein the second bore intersects the first bore such that at least a portion of the first bore is open to the second bore, wherein the distal section includes a plurality of substantially concave faces defining an outer profile thereof, the longitudinal axis being straight in the distal section.
 2. The intramedullary pin of claim 1, wherein the first bore intersects the second bore along an outer wall of the proximal section.
 3. The intramedullary pin of claim 1, further comprising a third proximal bore extending through the proximal section along a third bore axis, wherein the third proximal bore extends parallel to the second bore.
 4. The intramedullary pin of claim 3, further comprising a fourth proximal bore extending through the proximal section along a fourth bore axis, the fourth proximal bore having a substantially oval cross-section.
 5. The intramedullary pin of claim 4, wherein each of the first, second, third and fourth proximal bores are configured to receive a bone screw therethrough.
 6. The intramedullary pin of claim 1, further comprising first and second transverse distal bores extending through the distal section, a first distal bore axis of the first distal bore extending substantially parallel to a second distal bore axis of the second distal bore.
 7. The intramedullary pin of claim 6, further comprising a third transverse distal bore extending through the distal section, a third distal bore axis of the third distal bore being angularly offset from the first and second distal bore axes.
 8. The intramedullary pin of claim 1, wherein the proximal end includes a lateral bevel.
 9. The intramedullary pin of claim 8, wherein the proximal end further comprises a groove extending thereinto to aid in positioning of the intramedullary pin.
 10. The intramedullary pin of claim 1, wherein the concave faces extend from the distal end in a proximal direction.
 11. The intramedullary pin of claim 10, wherein the concave faces have a length from about 10 mm to about 40 mm.
 12. An intramedullary pin for insertion into a medullary cavity, comprising: an elongated shaft extending from a proximal end to a distal end along a central longitudinal axis, the shaft including a proximal section extending from the proximal end to a first end and a distal section extending from the first end to the distal end, wherein in the proximal section the longitudinal axis curves in a lateral-posterior direction from the proximal end to at least the first end; a first proximal bore extending through the proximal section along a first bore axis; and a second proximal bore extending through the proximal section along a second bore axis, wherein the first bore intersects the second bore such that at least a portion of the first bore is open to the second bore; wherein the distal section includes a plurality of angled faces distributed substantially evenly thereabout to define an outer profile thereof, the longitudinal axis being straight in the distal section.
 13. The intramedullary pin of claim 12, wherein a cross-sectional shape of the distal section is one of triangular and square.
 14. The intramedullary pin of claim 12, wherein the angled faces are concave.
 15. The intramedullary pin of claim 12, wherein the first bore intersects the second bore along an outer wall of the proximal section.
 16. The intramedullary pin of claim 12, further comprising a third proximal bore extending through the proximal section along a third bore axis, wherein the third proximal bore extends parallel to the second bore.
 17. The intramedullary pin of claim 16, further comprising a fourth proximal bore extending through the proximal section along a fourth bore axis, the fourth proximal bore having a substantially oval cross-section.
 18. The intramedullary pin of claim 12, further comprising first, second and third transverse distal bores extending through the distal section, a first distal bore axis of the first distal bore extending substantially parallel to a second distal bore axis of the second distal bore and a third distal bore axis of the third distal bore being angularly offset from the first and second distal bore axes.
 19. The intramedullary pin of claim 12, wherein the proximal end includes a lateral bevel. 